CPI is collaborating with partners GSK and AstraZeneca to establish a bespoke, continuous wet granulation manufacturing facility for small-scale development of oral solid dosage pharmaceuticals.
The new facility, built as part of a project called PROSPECT CP, will include blending and feeding of raw materials, twin screw wet granulation, drying and ultimately tabletting. Importantly, the facility is designed to include integrated in-line process analytical technologies (PAT).
This suite of analytical sensors is placed at the end of the granulator to monitor important in-process product attributes in real time.
Data from the in-line sensors will be used to build models, which will predict finished product attributes from the in-process measurements, enabling robust control of product quality to be achieved.
CPI is also working closely with a number of suppliers including GEA Group, Perceptive Engineering Ltd, Siemens Plc, Innopharma Labs Ltd and Kaiser Optical Systems Inc to create the facility, which will be based at CPI’s existing facilities at NETPark, Co. Durham.
Jason Crooks, Director, Drug Product Design and Development at GSK, commented: “GSK is proud to be working with CPI to develop the PROSPECT CP platform. The work progressed on PROSPECT CP over the next two years will provide a much-needed springboard to accelerate incubation and translation of emerging process analytical technologies to the pharma business.”
Handling APIs
The resource will be capable of handling a wide range of active pharmaceutical ingredients and will include equipment relevant to established continuous manufacturing technologies.
Once complete, the capability will be available as an in-line, PAT-enabled, open-innovation facility to support the UK pharmaceutical industry and potentially other industries where the development of controlled complex solid forms is critical.
It will be ideally suited to the rapid development of robust processes enabling reduced development timelines. However, it could also be used in the future to aid real-time monitoring and control of product quality.
The longer-term ambition is to reduce or remove the need for labour-intensive testing of products at the end of manufacture and decreasing drug release timeframes.
A prototype of the facility has been constructed, and work is continuing on the integration of sensors and controls with the manufacturing equipment.
Graeme Cruickshank, Director of Formulation at CPI, said: “We are delighted that CPI has been able to support this massive step forward in the understanding of complex particles. Creating the infrastructure needed to develop UK-led fundamental learning in this high-value area will enable us to drive innovation forward in the pharmaceutical sector, as well as many others."
For Kevin Sutcliffe, Principal Scientist, Global Product Development at AstraZeneca, creating the PAT test bed on the PROSPECT CP platform will enable the industry to acquire process data using new and existing analytical technologies.
“Our collaboration with CPI will complement our own work in AstraZeneca on building models that show the relevance of raw material characteristics and process measurements to product quality. We look forward to seeing the outputs of this new collaborative venture," Sutcliffe said.
Strategic project
The PROSPECT CP project builds on and complements CPI’s existing capability to study mixing and scale-up in complex liquid formulations. This follows on from the completion of another strategic project aiming to support the better implementation of computer models across manufacturing processes.
These activities are funded by the Innovate UK grant to establish the National Formulation Centre and support the centre’s strategic themes of predictive design and manufacturability, incorporating aspects of advanced modelling and PAT-enabled model-based process control to facilitate the adoption of digital manufacturing technologies across the formulation industry.